System for anchoring medical devices

ABSTRACT

Some embodiments of a medical device anchor system include an anchor device that receives a catheter (or other medical instrument) and secures the catheter in place relative to a skin penetration point. In some embodiments, the anchor device can secure the catheter in an operative position relative to the skin penetration point without use of suture or skin tapes.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 15/897,908filed on Feb. 15, 2018 (now U.S. Pat. No. 10,471,236), which is acontinuation of U.S. patent application Ser. No. 15/016,984 filed onFeb. 5, 2016 (now U.S. Pat. No. 9,919,134), which is a continuation ofU.S. patent application Ser. No. 14/134,590 filed Dec. 19, 2013 (nowU.S. Pat. No. 9,283,355), which is a divisional of U.S. patentapplication Ser. No. 13/542,080 filed on Jul. 5, 2012, (now U.S. Pat.No. 8,628,511) which is a divisional of U.S. patent application Ser. No.12/163,539 filed on Jun. 27, 2008 (now U.S. Pat. No. 8,235,948) byRosenberg et al. The contents of these previous applications are fullyincorporated herein by reference.

TECHNICAL FIELD

This document relates to an anchor device, such as a device for use insecuring the position of a catheter or other medical instrument.

BACKGROUND

Venous, arterial, and body fluid catheters are commonly used byphysicians. For example, such catheters may be used to gain access tothe vascular system for dialysis, for introducing pharmaceutical agents,for nutrition or fluids, for hemodynamic monitoring, and for blooddraws. Alternatively, catheters can be used for drainage of fluidcollections and to treat infection. Following introduction into thepatient, the catheter is secured to the patient. In conventionalpractice, the catheter is commonly secured to the patient using anadhesive tape on the skin or by suturing a catheter hub to the patient'sskin.

SUMMARY

Some embodiments of a medical device anchor system include an anchordevice that receives a medical instrument (such as a catheter or thelike) and secures the instrument in place relative to a skin penetrationpoint. In some circumstances, the anchor device can be designed to beinserted through the skin penetration point that is already occupied bythe medical instrument, thus allowing the anchor device to be used aftermedical instrument is already in place and reducing the need for asecond penetration point for the anchor device. In particularembodiments, the anchor device may have a multi-piece design that cansimplify post-operative removal and reduce trauma to surrounding tissuenear the skin penetration point. For example, the anchor device can beseparated into at least two portions prior to removal from the skinpenetration point. In these circumstances, the separable portions mayeach include a subcutaneous anchor, and each anchor can be removed fromthe skin penetration point independently of the other in a manner thatreduces the likelihood of damage to the tissue surrounding the skinpenetration point.

In some embodiments, an anchor device may include a retainer body toreleasably couple to a catheter. The retainer body may be separable intoa first body portion and a second body portion. The device may alsoinclude first and second anchors that extend distally from the retainerbody. Each anchor may comprise a flexible tine that is deployable in asubcutaneous region to secure the retainer body relative to apenetration point. The first anchor may be coupled to the first bodyportion, and the second anchor may be coupled to the second bodyportion. The first and second body portions may be releasably coupledtogether so that the first and second anchors are collectivelydeployable into the subcutaneous region. Also, the first and second bodyportions may be separable from one another when the first and secondanchors are deployed in the subcutaneous region so that the first anchoris removable from the subcutaneous region independent of the secondanchor.

Particular embodiments include an anchor system for securing theposition of a medical instrument. The system may include a medicalinstrument that is insertable into a skin penetration point. Also thesystem may include an anchor device comprising a retainer body and oneor more subcutaneous anchors. The retainer body may releasably securewith the medical instrument when the medical instrument is inserted intothe skin penetration point. The one or more anchors may extend distallyfrom the retainer body and toward the skin penetration point when themedical instrument is inserted into the skin penetration point. Eachanchor may comprise a tine that deploys in a subcutaneous region tosecure the retainer body relative to the skin penetration point.

In certain embodiments, a method of anchoring a catheter may includeadvancing a catheter though a skin penetration point. The method mayalso include directing an anchor device toward the skin penetrationpoint that is occupied by a portion of the catheter. The anchor devicemay comprise a retainer body to releasably couple to an external portionof the catheter arranged outside the body, and at least one anchorextending distally from the retainer body. The method may furtherinclude inserting the anchor through the skin penetration point that isoccupied by the catheter so that at least a portion of the anchor isdeployed in a subcutaneous region proximate the skin penetration point.

These and other embodiments may provide one or more of the followingadvantages. First, some embodiments of an anchor system can retain amedical instrument in a desired position relative to a skin penetrationpoint without necessarily requiring sutures or skin adhesives. Second,in some embodiments, an anchor device can include a retention portionthat readily mates with a medical instrument (such as a catheter) and atleast one anchor extending distally from the retention portion to engagethe skin penetration point as the medical instrument. Third, the anchordevice can include one or more anchors configured to deploy in asubcutaneous region under the skin proximate to the skin penetrationpoint of the medical instrument. In such circumstances, the anchors maybe inserted through the skin penetration point in a manner that reducesthe likelihood of trauma to the surround skin tissue. Fourth, in someembodiments, the anchor device may include multiple components that areseparable from one another before the anchor device is removed from theskin. For example, the anchor device may include a first portion and asecond portion that are coupled together (as the fully assembled anchordevice) during insertion into the skin penetration point, but the firstand second portions can be readily separated from one another tofacilitate removal from the skin. Accordingly, the anchors 120 a and 120b (including the tines 130 a and 130 b) can collectively penetrate intothe subcutaneous region 34 as part of the assembled device 100, and maybe separately and individually withdrawn from penetration point 34during the removal process. Such a configuration can permit the firstand second portions to be maneuvered in a manner that reduces thelikelihood of causing damage to the skin during removal of the anchors.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of an anchor device with a portion of thedevice located in a subcutaneous region, in accordance with someembodiments.

FIGS. 2A-2B are perspective views of the anchor device of FIG. 1 withthe medical device retention portion in open and closed positions,respectively.

FIG. 3A is a top view of the anchor device of FIG. 1.

FIG. 3B is a top view of a portion of the anchor device of FIG. 1 withthe anchors in a stressed position.

FIGS. 4A-4B are cross-sectional views of the anchor device of FIG. 3A.

FIGS. 5A-5D are perspective views of the anchor device of FIG. 1,depicting its removal from a subcutaneous region.

FIGS. 6A-6D are perspective views of the anchor device of FIG. 1,depicting its use in certain embodiments.

FIG. 7 is an exploded perspective view of an anchor device in accordancewith some embodiments.

FIGS. 8A-8F are perspective views of the anchor device of FIG. 7,depicting its use in particular embodiments.

FIGS. 9A-9B are perspective views of an alternative embodiment of theanchor device having a portion that can retain a catheter hub.

FIG. 10 is a perspective view of an alternative embodiment of the anchordevice, having an anchor tab, with a portion of the device located in asubcutaneous region.

FIGS. 11A-11B are perspective views of an alternative embodiment of theanchor device having a bent-wire anchor and a portion that can retain acatheter hub.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIG. 1, some embodiments of a medical device anchor system10 include an anchor device 100 that releasably retains a medicalinstrument 20 (e.g., depicted as a catheter in this embodiment) in anoperative position relative to a skin penetration point 32. The anchordevice 100 may include a retainer body 110 that receives the medicalinstrument 20 and can releasably engage with an outer surface of themedical instrument 20. The medical instrument 20 extends from theretainer body 110 and through the penetration point 32 in the patient'sskin 30 (e.g., through an incision or the like), while the retainer body110 remains outside of the skin 30. As described in more detail below,the anchor device 100 can secure the catheter 20 in the operativeposition relative to the penetration point 32 without necessarilyrequiring sutures or adhesive tapes bonded to the skin. For example, theanchor device 100 can include one or more anchors 120 a and 120 b thatextend distally from the retainer body 110 so as to penetrate throughthe same skin opening as the medical instrument 20. The anchors 120 aand 120 b can include tines 130 a and 130 b that, after insertion,reside in a subcutaneous region 34 (e.g., a region under the skin 30that may comprise a fatty tissue layer) so as to secure the position ofthe anchor device 100—and the medical instrument 20 retainedtherein—relative to the penetration point 32.

In some embodiments, the medical instrument 20 can include a catheter tobe inserted through the penetration point 32 of the skin 30 as part of amedical procedure. For example, in the embodiment depicted in FIG. 1, acentral venous catheter 20 can be inserted into a percutaneous openingsurgically formed in the skin (e.g., penetration point 32), to theunderside of the skin 30, and into a vein 40 to provide vascular accessfor delivering medications or minimally invasive devices into a patient.As described in greater detail below, after placement of the catheter20, the anchor device 100 (arranged in the open configuration as shownin FIG. 2A) can be inserted into the penetration point 32 such that thetips 122 a and 122 b (FIG. 2A) of the anchors 120 a and 120 b enter theskin 30 through the penetration point 32. As the anchor device 10 isinserted through the penetration point 32, the tines 130 a and 130 b arestressed to flex against anchor bodies 124 a and 124 b (FIG. 2A) to passthrough the penetration point with reduced trauma to the surroundingskin tissue. As the anchors 120 a and 120 b are collectively advancedthrough the penetration point 32, the tines 130 a and 130 b are movedbeneath the dermal layers 36 (e.g., the dermis, the epidermis, etc.) ofthe skin 30. When the tines 130 a and 130 b reach the subcutaneousregion 34, the tines 130 a and 130 b can return toward an unstressedshape (FIG. 2A) and thereby deploying in the subcutaneous region 34. Asshown in FIG. 1, the anchors 120 a and 120 b may be designed such thatthe tines 130 a and 130 b include a curvature that abuts against theunderside of the dermal layers 36 in a manner that reduces thelikelihood of the tine tips 132 a and 132 b (FIG. 2A) puncturing theunderside of the dermal layers 36. When the tines 130 a and 130 b of theanchors 120 a and 120 b are deployed in the subcutaneous region 34, theanchor device 100 can be secured to the patient without the retainerbody 110 penetrating though the skin 30 of the patient and withoutnecessarily requiring sutures or adhesive tapes bonded to the skin 30.

Referring now to FIGS. 1 and 2A-B, the retainer body 110 can include aninstrument retention portion 140 used to secure the catheter 20 (orother medical instrument) relative to the skin penetration point 32. Forexample, after the catheter 20 is delivered into the targeted vein 40(or other bodily lumen) and after the anchors 120 a and 120 b aredeployed in the subcutaneous region 34, the catheter 20 can be pressedagainst a foam adhesive pad 145 (FIG. 2A) to temporarily secure thecatheter relative to the retention portion 140. From there, the anchordevice 100 can be transitioned from the open configuration (shown inFIG. 2A) to a closed configuration (shown in FIGS. 1 and 2B) to therebysecure the catheter 20 with the retention portion 140. As described ingreater detail below, the catheter retention portion 140 of the retainerbody 110 can include retention members 150 and 160 (FIG. 2A) that can betransitioned from the open configuration to the closed configuration topress against and releasably retain the catheter 20 in a desiredposition. In this embodiment, the retention members 150 and 160 compriseadjustable wing include locking tabs 152 and 162 (FIG. 2A) thatpositively engage one another to releasably lock the retention portion140 in the closed position.

In some embodiments, the anchor device 100 can include features thatfacilitate separation from the catheter 20 and removal from the skin 30in a manner that reduces the likelihood of trauma to the skin 30surrounding penetration point 32. For example, tabs 152 and 162 may bedisengaged allowing the retention members 150 and 160 to shift away fromone another and return to the open configuration shown in FIG. 2A. Oncethe retention portion 140 is opened, the catheter 20 can be separatedfrom the anchor device 100 (e.g., by lifting the catheter 20 from theadhesive pad 145. As such, the catheter 20 can be moved independentlyfrom the anchor device 100, for example, to withdraw the catheter 20from the patient while the anchor device 100 remains secured to the skin30. In some embodiments, the anchor device 100 can include separableportions that can be disassembled prior to removal of the anchors 120 aand 120 b from the subcutaneous region 34. For example, in thisembodiment, the anchor device 100 comprises an assembly of two pieces101 a and 101 b (FIGS. 5A-B) that can separate from one another tofacilitate removal of the tine 130 a independent of the other tine 130b. Such a configuration permits the anchors 120 a and 120 b to bemaneuvered in a manner that reduces the likelihood of the tines 130 aand 130 b causing damage to the skin 30 during removal.

Referring now to FIGS. 2A and 2B, some embodiments of the anchor device100 can include structures designed to mate with portions of the medicalinstrument 20 to be retained by the anchor device 100. For example, inthis embodiment the, retainer body 110 defines a channel 112 thatextends longitudinally from the retention portion 140 toward the anchors120 a and 120 b. The channel 112 can be configured to complement anouter surface of the catheter 20 or other medical instrument to beanchored by the device 100. For example, during installation of theanchor device 100, the channel 112 can be guided longitudinally alongthe catheter 20 so that the anchors 120 a and 120 b are directed towardthe penetration point 32 through which the catheter 20 passes. Inaddition, the channel 112 can be aligned with a longitudinal opening 142defined by the retainer wings 150 and 160 when arranged in the closedconfiguration (FIG. 2B). As such, the catheter 20 can extend through thelongitudinal opening 142 and along the channel 112 when the anchors 120a and 120 b are deployed under the skin 30. As previously described,some embodiments of the anchor device 100 may include the adhesive pad145 to temporarily hold the catheter 20 or other medical instrument. Inthose embodiments, the adhesive pad 145 may be arranged longitudinallyadjacent to the channel 112 so that the catheter 20 or other medicalinstrument can be readily pressed against the adhesive pad 145 when thecatheter 20 or other medical instrument extends along the channel 112.The surface of the pad 145 can include a releasable adhesive that cantemporarily retain the catheter 20 in a desired position relative to theretainer body 110 and thereafter permit separation of the catheter 20from the device 100 (e.g., by peeling the catheter 20 away from the pad145). In this example, the releasable adhesive on the pad can beselected to provide a predetermined amount of holding force that willmaintain the catheter 20 or other medical device in place, but will notdamage the catheter 20 or other medical device upon separation.

It should be understood from the description herein that the retentionmembers 150 and 160 can be used in addition to, or as an alternative to,the adhesive pad 145. In the depicted embodiment, the adhesive pad 145serves as a supplement to the retention members 150 and 160 thatreleasably secure the catheter 20 or other medical device to the anchordevice 100. For example, after a catheter has been positioned such thatit is in contact with and releasably secured to the adhesive pad 145,force can be applied to the retention members 150 and 160 such that theypivot around axes 154 and 164 toward the closed configuration (FIG. 2B).As the retention members 150 and 160 transition toward the closedconfiguration, the tabs 152 and 162 move closer to one another. When thetab 162 engages the complementary tab 152 (e.g., in this embodiment, thetab 162 can “snap” into the slot 153), the retention members 150 and 160are releasably secured in the closed configuration (FIG. 2B) so as toapply a holding force to the catheter 20 or medical instrument therein.

Referring now to FIG. 2B, when the retention members 150 and 160 are inthe closed position surrounding a medical device, such as the catheter20 (FIG. 1), the catheter 20 can be retained in a substantially fixedposition relative to the anchor device 100. In this embodiment, theretention members 150 and 160 can surround the catheter 20 and apply theholding force to the outer surface of the catheter 20. For example, theretention members 150 and 160 may define the longitudinal opening 142 tohave a minor diameter that is slightly smaller than the outer surface ofthe catheter 20, thereby causing the retention members 150 and 160 tosqueeze upon the catheter 20 without damaging or affecting theperformance of the catheter 20. In some circumstances, the retentionmembers 150 and 160 can include an adhesive coating or adhesive padsalong the inner channels that define the longitudinal opening 142. Assuch, the adhesive coating or adhesive pads would be compressed againstthe catheter 20 to releasably secure the catheter within thelongitudinal opening 142. In alternative embodiments, the retentionmembers 150 and 160 can surround the catheter 20 without necessarilyapplying a holding force thereto. For example, the retention members 150and 160 can guard incidental contact to the catheter 20 or otherexternal forces that might otherwise cause the catheter 20 toprematurely peel away from the adhesive pad 145.

Referring again to FIGS. 2A-B, the retention members 150 and 160 can beseparated by disengaging the locking tabs 152 and 162 so as to removethe catheter 20 or other medical instrument that has been secured withinthe anchor device 100. For example, the retention members 150 and 160can be separated from each other by applying pressure to the tab 152such that the tab 152 is displaced enough to allow the tab 162 to exitslot 153, thus allowing the retention members 150 and 160 to return tothe open configuration. After the retention members 150 and 160 areshifted to the opened configuration (FIG. 2A), the catheter 20 can bepeeled away from the adhesive pad 145 to thereby free the catheter forwithdrawal from the skin penetration point 32.

Referring now to FIGS. 3A and 3B, the anchor device 100 can includefeatures that facilitate deploy of the anchors 120 a and 120 b into thesubcutaneous region in a manner that reduces the likelihood of damage tosurrounding tissue. For example, in some embodiments, the anchors 120 aand 120 b may comprise a material that exhibits superelasticity whenused in a patient's body. As such, when the tines 130 a and 130 b ofanchors 120 a and 120 b are stressed by insertion through the skinpenetration point 32, the tines 130 a and 130 b can superelasticallyflex from an expanded position (FIG. 3A) to a contracted position (FIG.3B). In this contracted position as shown in FIG. 3B, the tines 130 aand 130 b may flex against the anchor bodies 124 a and 124 b. Whileagainst the anchor bodies 124 a and 124 b, the tines 130 a and 130 b canreadily penetrate through the skin penetration point 32 (which may begenerally smaller in width than the width occupied by the tines 130 aand 130 b in a fully expanded state). Such anchor insertion techniquescan reduce the damage to the patient's skin 30 during deployment of theanchors 120 a and 120 b.

In some embodiments, at least portions of the anchors 120 a and 120 b(including the tines 130 a and 130 b) may be formed from a length ofnitinol wire or from a sheet of nitinol material, which has beenprocessed to exhibit superelasticity below or at about a normal humanbody temperature, such as below or at about 37 degrees C. The nitinolmaterial may comprise, for example, Nickel Titanium (NiTi), NiobiumTitanium (NbTi), or the like. Alternatively, the anchors 120 a and 120 bmay comprise a metal material such as stainless steel (e.g., 304stainless, 316 stainless, custom 465 stainless, and the like), springsteel, titanium, MP35N, and other cobalt alloys, or the like. In anotheralternative, the anchors 120 a and 120 b may be formed from a resilientpolymer material. In these embodiments, the anchors 120 a and 120 b canbe formed from a material or materials that allow the tines 130 a and130 b to be flexed to a contracted position (e.g., as in FIG. 3B) andcan resiliently return to an expanded position (e.g., as in FIG. 3A). Tofurther decrease the insertion profile of the anchors 120 a and 120 b asthey are inserted into the skin 30, the anchor bodies 124 a and 124 bcan include recesses, such as the recess 126 a and the correspondingrecess (not shown) in the anchor body 124 b into which at least aportion of the tines 130 a and 130 b can inwardly flex. As such, therecesses in the anchor bodies 124 a and 124 b can at least partiallyaccommodate the tines 130 a and 130 b when they are flexed into thecontracted position, thereby further reducing the insertion profile ofthe anchors 120 a and 120 b.

Referring now to FIGS. 4A-4B, the anchor device 100 can be formed frommultiple components that are separable from one another after insertioninto the patient but prior to removal from the patient. In thisembodiment, the anchor device 100 comprises a two-piece design in whicha first portion is separable from a second portion so as to facilitateremoval of the anchor device 100 from the skin 30. For example, theanchor device 100 can include an upper portion 101 a and a lower portion101 b, which can be separated from each other. The upper portion 101 acan include an upper main body 111 a coupled to the anchor 120 a, andthe lower portion 101 b can include a lower main body 111 b coupled tothe anchor 120 b. To remove the anchor device 100 from a patient, theanchor device 100 can be separated into two components (described inmore detail below in connection with FIGS. 5A-5D) allowing for easierremoval from a patient. When the upper portion 101 a is separated fromthe lower portion 101 b, the anchor 120 a can remain attached to theupper main body 111 a, while the anchor 120 b can remain attached to thelower main body 111 b. Thus, the first anchor 120 a can be manipulatedinside the subcutaneous region 34 (FIG. 1) by a user that handles thatupper main body 111 a outside the patient's body. Likewise, the secondanchor 120 b can be manipulated inside the subcutaneous region 34(FIG. 1) by the user that handles the lower main body 111 b. Such manualmanipulation of the first and second anchors 120 a and 120 b can be usedto readily remove the tines 130 a and 130 b through the skin penetrationpoint 32 while reducing the likelihood of trauma to the surround skintissue.

Referring now to FIGS. 5A-5D, as previously described, the upper portion101 a of the anchor device 100 can be separated from the lower portion101 b before removing the anchors 120 a and 120 b from the subcutaneousregion 34 under the skin 30. In some embodiments, the upper portion 101a and the lower portion 101 b are assembled together using a releasableadhesive coating along mating surfaces, one or more score lines or tearlines, or the like. As such, the upper portion 101 a and the lowerportion 101 b are coupled together (as the fully assembled anchor device100) prior to insertion into the skin penetration point, yet the upperportion 101 a and the lower portion 101 b can be readily separated afterthe anchors 120 a and 120 b are deployed in the subcutaneous region 34.Accordingly, the anchors 120 a and 120 b (including the tines 130 a and130 b) can collectively penetrate into the subcutaneous region 34 aspart of the assembled device 100, and may be separately and individuallywithdrawn from penetration point 34 during the removal process.

At least a portion of the upper portion 101 a and the lower portion 101b can comprise a polymer material (e.g., PVC, polypropylene,polystyrene, or the like). In such embodiments, the upper main body 111a and the lower main body 111 b can be formed using a molding process inwhich each of the main bodies 111 a and 111 b is overmolded around aportion of the associated anchor 120 a or 120 b. For example, the anchor120 b can include a proximal hub that has a larger cross-sectional areathat of the anchor body 124 b. During the manufacture of the lowerportion 101 b, the hub of the anchor body 124 b can be positioned insideof an injection mold for the lower main body 111 b such that when apolymer is injected to the mold, the polymer material can flow aroundthe hub 128 b to thereby couple the lower main body 111 b to the anchor120 b. The completed lower body 111 b will then at least partiallyencapsulate the hub 128 b, thus securing the anchor 120 b to the lowerbody 111 b. It should be understood from the description herein that theanchor 120 a can also include a hub so as to be coupled to the uppermain body 111 a in a similar overmolding process.

In some embodiments, the upper portion 101 a and the lower portion 101 bcan be manufactured as two separate components that are later joined(e.g., by an adhesive bond, by ultrasonic spot welds, or the like) in aseparable manner. In the embodiment depicted in FIGS. 5A-B, the twoportions 101 a and 101 b can be joined in an area adjacent to an orifice114. For example, during manufacturing of the anchor device 100, theindependent portions 101 a and 101 b can be temporarily held in place(e.g., as in FIG. 2A), while an adhesive is applied into the orifice114. After the adhesive cures, the portions 101 a and 101 b can be heldtogether by the cured adhesive alone, in the area proximate the orifice114 along interfacing surfaces 112 a and 112 b (FIGS. 5A-B). Theadhesive employed in this assembly process can be a releasable adhesivethat, during normal usage, retains the upper and lower portions 101 aand 101 b in the assembled state until the user desires to separate theinterfacing surfaces 112 a and 112 b. At such time, the user may apply aseparation force 170 (FIGS. 5A-B) to divide the anchor device 100 intothe two separate portions 101 a and 101 b. In addition or in thealternative to the releasable adhesive, the upper and lower portions 101a and 101 b may include plastic spot welds, frangible portions, or otherreleasable structures at interfacing regions to retain the portions 101a and 101 b in the assembled state (FIG. 2A).

Referring now to FIGS. 5B-5D, after the portions 101 a and 101 b areseparated from one another, the two portions 101 a and 101 b can bemaneuvered so as to withdraw the anchors 120 a and 120 b (including thetines 130 a and 130 b) through the penetration point 32 of the skin 30.In the example illustrated in FIGS. 5B-D, the lower portion 101 b can beheld substantially fixed relative to the penetration point 32 while theupper portion 101 a is maneuvered to individually remove the anchor 120a from the subcutaneous region 34. Removal in this manner can be used tolimit the cross sectional area of the portion of the anchor 120 a beingwithdrawn through the dermal layers 36, thus reducing the likelihood ofdamaging the surround skin tissue during removal of the anchor 120 a(refer to FIG. 5D). Once the upper portion 101 a is removed, the processcan be repeated for the lower portion 101 b.

Referring now to FIGS. 6A-6D, in use, the anchor system 100 can be usedto retain a medical instrument 20, such as a catheter, in an operativeposition relative to a skin incision. In some embodiments, thepenetration point 32 can be surgically opened in the skin 30, such thata catheter 20 can be inserted in the penetration point 32, through thesubcutaneous region 34, and into a vein 40. After the catheter 20 isinserted, the anchor device 100 can be used to secure the catheter 20relative to the penetration point 32.

As shown in FIG. 6A, the anchor device 100 can be guided along thecatheter 20 toward the skin 30 so that the anchor tips 122 a-b approachthe penetration point 32. The anchors 120 a and 120 b can be insertedinto the patient's skin 30 through the penetration point 32 (e.g.,through the same incision through which the catheter 20 was previouslyinserted) beginning with the tips 122 a and 122 b. As the anchors 120 aand 120 b are inserted into the skin 30, the tines 130 a and 130 b mayflex to the contract position, as previously described in connectionwith FIG. 3B. By resiliently flexing against the anchor bodies 124 a and124 b, the tines 130 a and 130 b can pass through the penetration point32 in a way that reduces the likelihood of damage to the tissuesurrounding the penetration point 32.

Referring now to FIG. 6B, after the anchors 120 a and 120 b penetratethe skin 30 so that the tines 130 a and 130 b pass into the subcutaneousregion 34, the tines 130 a and 130 b can resiliently return toward anexpanded position and thereby deploy in the subcutaneous region 34. Thecurved shape of the tines 130 a and 130 b can allow them to deployadjacent to and abut the underside of the skin 30 to anchor the device100 relative to the skin without tearing the dermal layers 36. To retainthe catheter 20 in an operative position, the catheter can be positionedalong the channel 112 of the retainer body and the adhesive pad 145, andthe user may apply a force 22 to engage the catheter 20 with theadhesive surface of the pad 145. The retainer members 150 and 160 canthen be transitioned to the closed configuration to thus retain thecatheter 20 in a desired position relative to the penetration point 32(as shown in FIG. 1). To reposition the catheter 20, the retentionmembers 150 and 160 can be separated by disengaging the tabs 152 and162, and the catheter 20 can be lifted from the adhesive pad 145 (whileapplying a stabilizing force to the anchor device 100). As the catheter20 is no longer secured in place by the anchor device 100, it can berepositioned (advanced distally or withdrawn proximally) before beingcoupled once again to the adhesive pad 145 and the retention members 150and 160 (as shown in FIG. 1).

As shown in FIG. 6C, the catheter 20 can be withdrawn from the patientseparately from the anchor device 100. In one example, after thecatheter procedure is complete, the retention members 150 and 160 can beshifted to the opened configuration. The catheter 20 is then free to bepeeled or lifted away from the adhesive pad 145 using a lifting force 24(while applying a stabilizing force to the anchor device 100). After thecatheter 20 is dissociated from the anchor device 100, the catheter 20can be removed from the skin 30 by application of a withdrawal force 26(while the anchor device 100 remains coupled to the skin 30).

Referring now to FIG. 6D, the anchor device 100 can be removed from thepatient's skin 30 in a manner that separately withdraws the anchors 120a and 120 b. As described previously in connection with FIGS. 5A-5D, theanchor device 100 can be separated into multiple components so as toindividually withdraw the anchors 120 a and 120 b from the skin 30. Inthe example depicted in FIG. 6D, the lower portion 101 b can be heldsubstantially fixed relative to the penetration point 32 while the upperportion 101 a is maneuvered to individually remove the anchor 120 a fromthe subcutaneous region 34. Once the upper portion 101 a is removed, theprocess can be repeated for the lower portion 101 b. In an alternativeexample, the upper portion 101 a can be held substantially fixedrelative to the penetration point 32 while the lower portion 101 b ismaneuvered to individually remove the anchor 120 b from the subcutaneousregion 34. Once the lower portion 101 b is removed, the process can berepeated for the upper portion 101 a. Such removal processes can be usedto limit the cross sectional area of the portion of the anchor 120 a or120 b being withdrawn through the dermal layers 36, thus reducing thelikelihood of damaging the surround skin tissue during removal of theanchor 120 a or 120 b.

Referring now to FIGS. 7 and 8A-F, some embodiments of an anchor device300 can employ different mechanisms for securing a medical instrument ina desired position. For example, the anchor device 300 can include aretainer body 310 having an instrument retention member 340 so as toapply a gripping force upon the medical instrument (e.g., a catheter inthis embodiment). As such, the retainer body 310 can releasably engage aportion of catheter 20 (via the adjustable retention member 340) outsidethe patient's body. Similar to previously described embodiments, one ormore flexible anchors 320 a and 320 b extend distally from the retainerbody 310 for insertion in a subcutaneous region proximate a skinpenetration point while the retainer body 310 is arranged outside thepatient's body.

As shown in FIG. 7, in this embodiment, the retention member 340 may beremovably attached to the retainer body 310 using one or more apertures341 and 349 that mate with corresponding extensions 351 and 359. Theretention member may comprise a flexible material, such as silicone oranother biocompatible polymer material. For example, at least a flexiblewall portion 342 may comprise silicone or another biocompatible polymermaterial so that a second region 343 b can flexibly adjust relative to afirst region 343 a. In such circumstances, the apertures 341 and 349 canbe forced over the corresponding extensions 351 and 359, and thereafter(if desired) one aperture 349 can be lifted from the retainer body 310while the second aperture 341 remains secured to the retainer body 310(as described below, for example, in connection with FIGS. 8A-C).

As previously described, the retention portion 340 can secure thecatheter 20 (or another medical instrument) relative to a skinpenetration point. For example, after the catheter 20 is delivered intothe targeted vein 40 (or other bodily lumen) and after the anchors 320 aand 320 b are deployed in the subcutaneous region (proximate to the skinpenetration point), the retention member 340 can be adjusted so that thecatheter 20 is gripped inside a channel 345. In particular, theretention member 340 can be transitioned from an open configuration(shown in FIG. 8A) to a closed configuration (shown in FIG. 8B) tothereby secure the catheter 20 with the retention portion 340. Thechannel 345 may be at least partially defined by a wall comprisingsilicone or another flexible polymer that compresses against, andapplies a holding force to, the outer surface of the catheter 20. Assuch, in some embodiments, the anchor device 300 can secure to catheter20 without the use of an adhesive pad. It should be understood from thedescription herein that, in alternative embodiments, the anchor device300 may include an adhesive pad to supplement the holding forces appliedby the retention member 340.

Still referring to FIG. 7, the retainer body 310 may define a guidechannel 312 that extends longitudinally from the retention portion 340toward the anchors 320 a and 320 b. Similar to previously describedembodiments, the guide channel 312 can be configured to abut with anouter surface of the catheter 20 or other medical instrument to beanchored by the device 300. For example, during installation of theanchor device 300, the guide channel 312 can be slid longitudinallyalong the catheter 20 so that the anchors 320 a and 320 b are directedtoward a skin penetration point through which the catheter 20 passes. Inaddition, the channel 312 can be aligned with the gripping channel 345defined by the retention member 340 when arranged in the closedconfiguration (FIG. 8B). As such, the catheter 20 can extend through thegripping channel 345 and along the guide channel 312 when the anchors320 a and 320 b are deployed under the skin.

In use, the anchor device 300 can include features that facilitateseparation from the catheter 20 and removal from the skin in a mannerthat reduces the likelihood of trauma to the skin surroundingpenetration point. For example, the retention member 340 can include atab 348 that can be readily grasped by a user to lift the second region343 b from the retainer body 310, thereby opening the channel 345 forremoval of the catheter 20. After the retention portion 340 is shiftedto the open configuration (FIG. 8C), the catheter 20 can be separatedfrom the channel and moved independently from the anchor device 300(e.g., to withdraw the catheter 20 from the patient while the anchordevice 300 remains secured to the skin as shown in FIG. 8D). Moreover,similar to previously described embodiments, the anchor device 300 caninclude separable portions that can be disassembled prior to removal ofthe anchors 320 a and 320 b from the subcutaneous region. For example,in this embodiment, the anchor device 300 comprises an assembly of twopieces 301 a and 301 b (FIGS. 8E-F) that can separate from one anotherto facilitate removal of the tine 330 b independent of the other tine330 a. Such a configuration permits the anchors 320 a and 320 b to bemaneuvered in a manner that reduces the likelihood of causing damage tothe skin during removal.

Referring now to FIGS. 8A-F, the anchor system 100 may retain themedical instrument, such as the catheter 20, in an operative positionrelative to a skin penetration point 32. In some embodiments, thepenetration point 32 can be surgically opened in the skin 30, such thata catheter 20 can be inserted in the penetration point 32, through thesubcutaneous region 34, and into a vein 40. After the catheter 20 isinserted, the anchor device 300 can be used to secure the catheter 20relative to the penetration point 32. In particular, the anchors 320 a-bmay be deployed in the subcutaneous region under the skin (proximate tothe skin penetration point) while the retainer body 310 remains outsidethe skin to secure with the catheter.

As shown in FIG. 8A, in some implementations, the anchor device 300 canbe guided along the catheter 20 toward the skin 30 so that the anchortips 322 a-b (FIG. 7) approach the penetration point 32. In thisexample, the retention member 340 is removably attached to the retainerbody 310 and is arranged in the open configuration. In thesecircumstances, the guide channel 312 an exposed portion of the grippingchannel 345 can be guided longitudinally along the catheter 20 so thatthe anchors 320 a and 320 b are directed toward the skin penetrationpoint 32. The anchors 320 a and 320 b can be inserted into the patient'sskin 30 through the penetration point 32 (e.g., through the same openingthrough which the catheter 20 was previously inserted) beginning withthe tips 322 a and 322 b. As the anchors 320 a and 320 b are insertedinto the skin 30, the tines 330 a and 330 b may resiliently flex againstthe anchor bodies 324 a and 324 b (FIG. 7) to a contracted position(similar to previously described embodiments). As such, the tines 330 aand 330 b can pass through the penetration point 32 in a way thatreduces the likelihood of damage to the tissue surrounding thepenetration point 32. When the anchors 320 a and 320 b are collectivelyadvanced through the penetration point 32, the tines 330 a and 330 b aremoved beneath the dermal layers 36 (e.g., the dermis, the epidermis,etc.) of the skin 30. After the tines 330 a and 330 b reach thesubcutaneous region 34, the tines 330 a and 330 b can return toward acurved shape (FIG. 7) and thereby deploy in the subcutaneous region 34.The anchors 320 a and 320 b may be designed such that the tines 330 aand 330 b include a curvature that abuts against the underside of thedermal layers 36 in a manner that reduces the likelihood of the tips 322a and 322 b puncturing the underside of the dermal layers 36. Aspreviously described, when the tines 330 a and 330 b are deployed in thesubcutaneous region, the anchor device 300 can be secured to the patientwithout the retainer body 310 penetrating though the skin 30 of thepatient and without necessarily requiring sutures or adhesive tapesbonded to the skin 30.

Referring now to FIG. 8B, the retention portion 340 can secure thecatheter 20 relative to the skin penetration point 32 for a period oftime in which the catheter 20 is used for treatment. For example, afterthe catheter 20 is delivered into the targeted vein 40 (or other bodilylumen) and after the anchors 320 a and 320 b are deployed in thesubcutaneous region 34, the retention member 340 can be adjusted so thatthe catheter 20 is held inside the channel 345. In particular, theretention member 340 can be transitioned from the open configuration(FIG. 8A) to the closed configuration (shown in FIG. 8B) to therebysecure the catheter 20 with the retention portion 340. To retain thecatheter 20 in this operative position, the user may grasp the tab 348and apply a force 355 to adjust the second region 343 b of the retentionmember 340 toward the mating extension 359. As previously described, theflexible wall 342 of the retention member 340 may act as a hinge-likeconnection between the second region 343 b and the first region 343 a sothat the retention member 340 can be transitioned from the openconfiguration (FIG. 8A) to the closed configuration (shown in FIG. 8B).When transitioned to the closed configuration, the gripping channel 345at least partially surrounds the catheter 20 and applies a holding forcethereto. For example, the wall of the channel 345 may comprise siliconeor another flexible polymer material that is configured to compressagainst the catheter's outer surface and thereby retain the catheter 20in the selected position relative to the penetration point 32. Toreposition the catheter 20, the retention member 340 can be adjusted tothe open configuration (refer to FIG. 8A), and the catheter 20 can berepositioned (advanced distally or withdrawn proximally) before beingcoupled once again to the retention member 340 (as shown in FIG. 8B).

As shown in FIGS. 8C-D, the catheter 20 can be withdrawn from thepatient separately from the anchor device 300. In this embodiment, afterthe catheter treatment is complete or the catheter 20 is otherwise readyto be removed, the retention member 340 can be shifted to the openedconfiguration (FIG. 8C). For example, the user may grasp the tab 348 andapply a force 356 (FIG. 8C) to adjust the second region 343 b of theretention member 340 away the mating extension 359. Such adjustment ofthe retention member 340 can at least partially open the grippingchannel 345 so that the catheter 20 can be moved independently from theanchor device 300. After the catheter 20 is dissociated from the anchordevice 300, the catheter 20 can be removed from the skin 30 byapplication of a withdrawal force 27 (FIG. 8D). In this embodiment, thecatheter 20 is withdrawn from the skin 30 while the anchor device 300remains coupled to the skin 30 via the anchors 320 a-b deployed in thesubcutaneous region 34. The guide channel 312 of the retainer body 310may provide guidance for the catheter 20 as it is withdrawn, therebyreducing the likelihood of tearing or damaging the skin around thepenetration point 32. Optionally, the retention member 340 can be fullyremoved from the retainer body 310. For example, the retention member340 can be lifted from the retainer body 340 (e.g., by application of aremoval force 357) before the catheter 20 is withdrawn from the skin 30.As such, the catheter 20 can be withdrawn without interference from theretention member 340. Alternatively, the retention member 340 may remainin the open configuration (FIG. 8C) during withdrawal of the catheter20.

Referring now to FIGS. 8E-F, the anchor device 300 can be removed fromthe patient's skin 30 in a manner that separately withdraws the anchors320 a and 320 b. As previously described, the anchor device 300 can beseparated into multiple components so as to individually withdraw theanchors 320 a and 320 b from the skin 30. For example, as shown in FIG.8E, a first portion 301 a of the anchor device 300 can be separated froma second portion 301 b before removing the anchors 320 a and 320 b fromthe subcutaneous region 34 under the skin 30. In this embodiment, thefirst portion 301 a and the second portion 301 b may be assembledtogether using a releasable adhesive coating along mating surfaces 312 aand 312 b. As such, the first portion 301 a and the second portion 301 bare coupled together (as the fully assembled anchor device 300) prior toinsertion into the skin penetration point, yet the first portion 301 aand the second portion 301 b can be readily separated after the anchors320 a and 320 b are deployed in the subcutaneous region 34. Accordingly,the anchors 320 a and 320 b (including the tines 330 a and 330 b) cancollectively penetrate into the subcutaneous region 34 as part of theassembled device 100, and may be separately and individually withdrawnfrom penetration point 34 during the removal process.

Similar to previously described embodiments, at least a portion of thefirst portion 301 a and the second portion 301 b can comprise a polymermaterial (e.g., PVC, polypropylene, polystyrene, or the like). In suchembodiments, first and second main bodies 311 a-b of the retainer body310 can be formed using a molding process in which each of the first andsecond main bodies 311 a and 311 b is overmolded around a portion of theassociated anchor 320 a or 320 b. In some embodiments, the first portion301 a and the second portion 301 b can be manufactured as two separatecomponents that are later joined (e.g., by an adhesive bond, byultrasonic spot welds, or the like) in a separable manner. In theembodiment depicted in FIG. 8E, the two portions 301 a and 301 b can betemporarily held in place while an adhesive is used to releasably bondthe mating surfaces 312 a-b. In some circumstances, the adhesive may beapplied through an orifice (not shown in FIG. 8E) in the area proximateto the interfacing surfaces 312 a and 312 b. The adhesive employed inthis assembly process can be a releasable adhesive that, during normalusage, retains the upper and lower portions 301 a and 301 b in theassembled state until the user desires to separate the interfacingsurfaces 312 a and 312 b. At such time, the user may apply a separationforce 370 (FIG. 8E) to divide the anchor device 300 into the twoseparate portions 301 a and 301 b. In addition or in the alternative tothe releasable adhesive, the upper and lower portions 301 a and 301 bmay include plastic spot welds, frangible portions or break lines, orother releasable structures at interfacing regions to releasably retainthe portions 301 a and 301 b in the assembled state.

As shown in FIG. 8F, after the first and second portions 301 a and 301 bare separated from one another, the two portions 301 a and 301 b can bemaneuvered so as to individually withdraw the anchors 320 a and 320 b(including the tines 330 a and 330 b) through the penetration point 32of the skin 30. In this example, the first portion 301 a can be heldsubstantially stationary while the second portion 301 b is maneuvered toindividually remove the anchor 320 b from the subcutaneous region 34.Removal in this manner can be used to limit the cross sectional area ofthe portion of the anchor 320 b being withdrawn through the dermallayers 36, thus reducing the likelihood of damaging the surround skintissue during removal of the anchor 320 b. Once the second portion 301 bis removed, the process can be repeated for the first portion 301 a. Inan alternative example, the second portion 301 b can be heldsubstantially stationary relative to the penetration point 32 while thelower portion 301 b is maneuvered to individually remove the anchor 320a from the subcutaneous region 34. After the first portion 320 a isremoved, the process can be repeated for the second portion 301 b. Aspreviously described, such a removal process can be used to reduce thelikelihood of damaging the surround skin tissue during removal of theanchor 320 a or 320 b.

Referring now to FIGS. 9A-B, alternative embodiments of the anchordevice can employ different mechanisms for securing medical instrumentto the anchor device. For example, the anchor device 700 can include aretainer body 710, anchors 720 a and 720 b, and a retention portion 740that can be used to secure a catheter 50 in an operative positionrelative to a skin incision. The catheter 50 can include a catheter hub52 and wings 54 that mate with the retention portion 740 to secure thecatheter 50 to the anchor device 700. In use, the catheter 50 can beinserted into a patient's skin through an incision (e.g., similar to theembodiment depicted in FIG. 6A) and into a targeted vein or bodilycavity. The anchor device 700 can be directed along the catheter 50toward the skin so that the distal tip 702 (defined by the distalanchors 720 a and 720 b) approach the penetration point in the skin. Asthe anchor device 700 penetrates the skin, the flexible tines 730 a and730 b can be stressed to flex against the anchor bodies 724 a and 724 b(similar to the embodiments described in connection with FIG. 3B),thereby reducing the likelihood of damaging the skin through which theanchor device 700 is being inserted. After the flexible tines 730 a and730 b are arranged in the subcutaneous region under dermal layers, thetines 730 a and 730 b can resiliently deploy to an expanded position(similar to the position shown in FIG. 9A).

To secure the catheter 50 to the anchor device 700, the catheter hub 52can be lowered into the retention portion 740 of the anchor device 700such that the alignment pegs 742 enter orifices 55 in the catheter hub52. After the catheter hub 52 is arranged within the retention portion740 such that the pegs 742 mate with the orifices 55 the retentionmembers 750 can be adjusted to a closed configuration (FIG. 9B). In suchcircumstances, the catheter 50 is coupled to the anchor device 700,which is anchored to the skin penetration point. After the catheterprocedure is complete, the catheter 50 can be readily separated from theanchor device 700. For example, the retention members 750 can beadjusted to an opened configuration (FIG. 9A) so that the catheter hub52 can lift from the anchor device 700 (while stabilizing the anchordevice 700). After the catheter 50 is withdrawn, the anchor device 700can be removed from the patient's skin in a manner that separatelywithdraws the anchors 720 a and 720 b. Similar to the embodimentspreviously in connection with FIGS. 5A-5D, the anchor device 100 can beseparated into multiple components so as to individually withdraw theanchors 720 a and 720 b from the skin. In one example, a lower main bodyportion 711 b can be held substantially fixed relative to thepenetration point while an upper main body portion 711 a (with theretention portion 740 coupled thereto) is maneuvered to individuallyremove the anchor 720 a from the subcutaneous region. Once the uppermain body portion 711 a is removed, the process can be repeated for thelower main body portion 711 b.

Referring now to FIG. 10, some embodiments of the anchor device canemploy alternative features for securing the anchor device to the skin.For example, an anchor device 800 can include a hooked anchor 820 inwhich a portion of the anchor (tine 830) resides in the subcutaneousregion 34 while the remaining portion of the anchor 820 (anchor body 810and guide prongs 812) reside outside the skin 30. Similar to previouslydescribed embodiments, the anchor device 800 includes a retentionportion 840 that is configured to engage a medical instrument 20 (suchas a catheter) while an anchor 820 extends distally from the retentionportion and into the same skin penetration point 32 as the catheter 20.

As shown in FIG. 10, the catheter 20 can be inserted into the patient'sskin 30 through the penetration point 32. After insertion of thecatheter 20, at least a portion of the anchor device 800 (e.g., a tine830) can be inserted through the same penetration point 32 that thecatheter 20 was previously inserted through. (It should be understoodfrom the description herein that, in alternative embodiments, the anchordevice 800 can be directed through the skin penetration point 32 beforethe catheter 20 is advanced therethrough.) As the tine 830 is inserted,the anchor device 800 can be pivoted to cause a distal tip 822 of theanchor 820 to pass into the skin along with the tine 830. As such, thetop face 832 of the tine 830 can abut the underside of the skin 30 toretain the anchor device 800 in place. Thus, the tine 830 may serve asan atraumatic hook device that is arranged in the subcutaneous region.In this embodiment, the catheter 20 can be positioned between two guideprongs 812 of the anchor body 810 and on top of an adhesive pad (notshown) included in a retention portion 840. The adhesive pad in theretention portion 840 can be similar to the adhesive pad 145 previouslydescribed in connection with FIGS. 2A-B. After the catheter 20 ispositioned between the two guides 812 and on top of the adhesive pad,retention members 850 and 860 can be transitioned from an openconfiguration to a closed configuration to secure the catheter 20relative to the anchor device 800. As with previously describedembodiments, the catheter 20 can be removed separately from the anchordevice 800. After the catheter 20 is withdrawn from the skin 30, theanchor device 800 can be manipulated to pivot the anchor 820 and slidethe tine 830 out of the skin 30 in a manner that reduces the likelihoodof damage to the surrounding skin tissue.

Referring now to FIGS. 11A-11B, alternate embodiments of an anchordevice 900 can include an alternative anchor configuration to secure theanchor device to the skin penetration point. Similar to previouslydescribed embodiments, the anchor device 900 includes a retentionportion 940 that is configured to engage a medical instrument 50 (suchas a catheter) while an anchor 920 extends distally from the retentionportion and into the same skin penetration point 32 as the catheter 50.In this example, the anchor device 900 includes a hooked anchor 920 inwhich a portion of the anchor (a tine configured as arm 932) resides inthe subcutaneous region 34 while another portion of the anchor 920extends outside the skin 30 to couple with the retention portion 940.The retention portion 740 can mate with a catheter hub 52 of thecatheter 50 to secure the catheter 50 in a desired position relative tothe skin penetration point.

In use, the catheter 50 can be inserted into a patient's skin through anincision (e.g., similar to the embodiment depicted in FIG. 6A) and intoa targeted vein or bodily cavity. The anchor device 900 can be directedtoward the skin so that the arm 932 of the anchor reaches the skinpenetration point. The anchor device 900 can be directed through theskin penetration point before or after the catheter 50 is advancedtherethrough. As the arm 932 is inserted, the anchor device 900 can bepivoted to cause a distal tip 922 of the anchor 920 to pass into theskin along with the arm 932. As such, the arm 932 can abut the undersideof the skin to retain the anchor device 900 in place. Similar toembodiments previously described in connection with FIG. 10, the arm 932of the anchor 920 may serve as an atraumatic hook device that isarranged in the subcutaneous region.

To secure the catheter 50 to the anchor device 900, the catheter hub 52can be lowered into the retention portion 940 of the anchor device 900such that the alignment pegs 952 enter orifices 55 in the catheter hub52. After the catheter hub 52 is arranged within the retention portion940 such that the pegs 952 mate with the orifices 55, the retentionmembers 950 can be adjusted to a closed configuration (FIG. 11B). Insuch circumstances, the catheter 50 is coupled to the anchor device 900,which is anchored to the skin penetration point. After the catheterprocedure is complete, the catheter 50 can be readily separated from theanchor device 900 by adjusting the retention members 750 to an openedconfiguration (FIG. 11A) and lifting the catheter hub 52 away from theanchor device 900. After the catheter 50 is withdrawn, the anchor device900 can be manipulated to pivot the anchor 920 and slide the arm 932 outof the skin in a manner that reduces the likelihood of damage to thesurrounding skin tissue.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

What is claimed is:
 1. An anchor device for securing a position of amedical instrument, comprising: a retainer body releasably engageablewith the medical instrument, the retainer body comprising a flexibleportion adjustable from a first configuration to a second configuration;a first anchor comprising a first external shaft portion, the firstanchor configured to extend distally from a distal end of the retainerbody and toward a skin penetration point when the medical instrument isinserted into the skin penetration point and engaged with the retainerbody; and a second anchor comprising a second external shaft portion,the second anchor configured to extend distally from the distal end ofthe retainer body and toward the skin penetration point when the medicalinstrument is inserted into the skin penetration point and engaged withthe retainer body, the first and second external shaft portions arepositionable side-by-side during insertion through the skin penetrationpoint into a subcutaneous region proximate the skin penetration point,and the first and second external shaft portions are movable relative toone another during removal from the subcutaneous region.
 2. The deviceof claim 1, wherein the retainer body is configured to engage with anexterior of the medical instrument in the second configuration.
 3. Thedevice of claim 2, wherein the first configuration is an open positionin which the medical instrument is movable independent from the retainerbody.
 4. The device of claim 1, wherein the flexible portion comprises ahinged connection between first and second body portions.
 5. The deviceof claim 1, wherein the first and second anchors extend distally fromthe distal end of the retainer body such that the retainer body isarranged external to the skin penetration point when the first andsecond anchors are deployed in the subcutaneous region.
 6. The device ofclaim 1, wherein each of the first and second external shaft portionsextend for a longitudinal length that is greater than a maximum widthand a maximum thickness of a respective external shaft portion of thefirst and second external shaft portions.
 7. The device of claim 1,wherein the first anchor is removable from the subcutaneous regionindependent of the second anchor.
 8. The device of claim 7, wherein theretainer body is separable into a first body portion and a second bodyportion, and the first anchor is coupled to the first body portion andthe second anchor is coupled to the second body portion.
 9. The deviceof claim 8, wherein the retainer body defines a gripping channel that atleast partially surrounds the medical instrument when the retainer bodyengages the medical instrument.
 10. The device of claim 9, wherein theretainer body defines a medical instrument receiving channel extendingalong a longitudinal axis, and wherein the first and second externalshaft portions of the first and second anchors extend generally parallelto the longitudinal axis of the medical instrument receiving channel.11. The device of claim 1, wherein the retainer body comprises a capmember and a lower body member.
 12. The device of claim 11, wherein thecap member is releasably engageable with the lower body member via anengagement structure of the cap member configured to mate with acorresponding engagement structure of the lower body member.
 13. Thedevice of claim 12, wherein the cap member and the lower body member areconfigured to releasably engage with an exterior of the medicalinstrument when the medical instrument is inserted into the skinpenetration point.
 14. The device of claim 13, wherein the lower bodymember of the retainer body is separable into a first body portion and asecond body portion.
 15. An anchor device for securing a position of amedical instrument, comprising: a retainer body releasably engageablewith the medical instrument, the retainer body comprising a flexibleportion adjustable from a first configuration in which the medicalinstrument is movable independent from the retainer body to a secondconfiguration in which the retainer body is configured to engage with anexterior of the medical instrument; a first anchor comprising a firstexternal shaft portion, the first anchor configured to extend distallyfrom a distal end of the retainer body and toward a skin penetrationpoint when the medical instrument is inserted into the skin penetrationpoint and engaged with the retainer body; and a second anchor comprisinga second external shaft portion, the second anchor configured to extenddistally from the distal end of the retainer body and toward the skinpenetration point when the medical instrument is inserted into the skinpenetration point and engaged with the retainer body, the first andsecond external shaft portions are movable relative to one anotherduring removal from a subcutaneous region.
 16. The device of claim 15,wherein the retainer body is separable into a first body portion and asecond body portion, and the first anchor is coupled to the first bodyportion and the second anchor is coupled to the second body portion. 17.The device of claim 16, wherein the flexible portion comprises a hingedconnection between the first and second body portions.
 18. The device ofclaim 16, wherein the retainer body defines a medical instrumentreceiving channel extending along a longitudinal axis, and wherein thefirst and second external shaft portions of the first and second anchorsextend generally parallel to the longitudinal axis of the medicalinstrument receiving channel.
 19. The device of claim 15, the firstanchor further comprising a first subcutaneous tine extendingorthogonally from a distal end of the first external shaft portion andthe second anchor further comprising a second subcutaneous tineextending orthogonally from a distal end of the second external shaftportion, wherein the first and second anchors extend distally from thedistal end of the retainer body such that the retainer body is arrangedexternal to the skin penetration point when the first and secondsubcutaneous tines are deployed in the subcutaneous region.